drugset / Trial / NCT00612170

A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

NCT00612170 ↗

Phase 3 Completed 1129 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.

Timeline

Start
2007-12
Primary completion
2009-05
Completion
2009-05

Outcome

Met primary endpoint

paper Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score (P≤0.025), the FIQ score (P≤0.023) PMID 22275142 ↗

release “trial conducted by Pfizer in 1,122 patients with fibromyalgia treated with esreboxetine or placebo for 14 weeks, the study met the two primary endpoints” pfizer.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject [S,S]-Reboxetine Unknown 4 mg Oral
Subject [S,S]-Reboxetine Unknown 8 mg Oral
Subject [S,S]-Reboxetine Unknown 10 mg Oral

Indications